System and apparatus comprising a multi-sensor catheter for right heart and pulmonary artery catheterization

Inventors

GLOVER, Christopher • Caron, Eric • ABEL, Sylvain

Assignees

Hemocath Ltd

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Publication Number

US-10463259-B2

Patent

Publication Date

2019-11-05

Expiration Date


Abstract

A system and apparatus comprising a multi-sensor catheter for right heart and pulmonary artery catheterization is disclosed. The multi-sensor catheter comprises multi-lumen catheter tubing into which at least three optical pressure sensors, and their respective optical fibers, are inserted. The three optical pressure sensors are arranged within a distal end portion of the catheter, spaced apart lengthwise within the distal end portion for measuring pressure concurrently at each sensor location. The sensor locations are configured for placement of at least one sensor in each of the right atrium, the right ventricle and the pulmonary artery, for concurrent measurement of pressure at each sensor location. The sensor arrangement may further comprise an optical thermo-dilution sensor, and another lumen is provided for fluid injection for thermo-dilution measurements. The catheter may comprise an inflatable balloon tip and a guidewire lumen, and preferably has an outside diameter of 6 French or less.

Core Innovation

The invention provides a multi-sensor catheter for right heart and pulmonary artery catheterization using multi-lumen catheter tubing with an atraumatic distal tip and an outside diameter of ≤48 French. The distal end portion includes a sensor arrangement with at least three spaced-apart optical pressure sensors positioned lengthwise so that pressure sensor locations are configured to place at least one sensor in each of the right atrium, the right ventricle, and the pulmonary artery during right heart and pulmonary artery catheterization.

Each optical pressure sensor is optically coupled to an individual optical fiber. The optical fibers extend to a proximal end that is coupled to an optical input/output connector for connection to an optical control system, enabling concurrent blood pressure measurements. Apertures in the catheter tubing are positioned adjacent each optical pressure sensor for fluid contact to support real-time pressure waveform measurement at the sensor locations.

The sensor placement and spacings are configured to provide concurrent blood pressure measurements at the optical pressure sensor locations, including a sensor arrangement for concurrent pressure measurements across multiple locations within the right heart and pulmonary artery. In pediatric or neonatal configurations, the catheter outside diameter is ≤3 French and the concurrent pressure waveforms are configured to include a right atrial pressure waveform, a right ventricular waveform, a pulmonary artery waveform, and a pulmonary capillary wedge position waveform.

Claims Coverage

The document presents three independent claims, each covering a multi-sensor catheter architecture that enables concurrent blood pressure measurements using optical sensors coupled via optical fibers, with additional structural and patient-population constraints in the independent variants.

Multi-sensor optical catheter with concurrent RA/RV/PA pressure sensing

A multi-sensor catheter for right heart and pulmonary artery catheterization with multi-lumen catheter tubing having an outside diameter of ≤48 French and an atraumatic tip, a plurality of optical sensors coupled to a plurality of optical fibers, sensors spaced apart lengthwise in a distal end portion with fluid-contact apertures adjacent each optical pressure sensor, and pressure sensor locations and spacings configured to place at least one pressure sensor in the right atrium, right ventricle, and pulmonary artery during catheterization for concurrent blood pressure measurements.

Pediatric/neonatal multi-sensor optical catheter with concurrent waveform measurement including PCWP

A multi-sensor catheter for right heart and pulmonary artery catheterization in pediatric or neonatal patients with multi-lumen catheter tubing having an outside diameter of ≤3 French and an atraumatic tip, optical sensors coupled to optical fibers inserted into respective lumens and spaced apart lengthwise in a distal end portion with apertures adjacent each optical pressure sensor for fluid contact, and pressure sensor locations and spacings configured to measure concurrent pressure waveforms for at least two locations within the right heart and pulmonary artery comprising a right atrial pressure waveform, a right ventricular waveform, a pulmonary artery waveform, and a pulmonary capillary wedge position waveform to provide concurrent blood pressure measurements at each optical pressure sensor location.

Upper/lower arm insertion multi-sensor optical catheter with concurrent waveform measurement including PCWP

A multi-sensor catheter for right heart and pulmonary artery catheterization with multi-lumen catheter tubing having an outside diameter sized to allow insertion through a vein in an upper or lower arm and an atraumatic tip, optical sensors coupled to optical fibers inserted into respective lumens and spaced apart lengthwise in a distal end portion with apertures adjacent each optical pressure sensor for fluid contact, and pressure sensor locations and spacings configured to measure concurrent pressure waveforms for at least two locations within the right heart and pulmonary artery comprising a right atrial pressure waveform, a right ventricular waveform, a pulmonary artery waveform, and a pulmonary capillary wedge position waveform to provide concurrent blood pressure measurements at each optical pressure sensor location.

Across the independent claims, the core inventive approach is a multi-lumen catheter that positions multiple optical pressure sensors at spaced locations along a distal end portion and couples each sensor to an optical fiber connected to an optical input/output connector, thereby configuring sensor locations to obtain concurrent blood pressure measurements from multiple right heart and pulmonary artery sites; the pediatric/neonatal and arm-insertion independent variants further constrain catheter outside diameter and specify concurrent waveform sets including PCWP.

Stated Advantages

Enables concurrent blood pressure measurements at multiple optical pressure sensor locations within the right heart and pulmonary artery.

Provides concurrent pressure waveform measurement including right atrial, right ventricular, pulmonary artery, and pulmonary capillary wedge position waveforms in the pediatric/neonatal and arm-insertion independent embodiments.

Documented Applications

ICU monitoring and diagnostic uses via concurrent right atrium/right ventricle/pulmonary artery (and pulmonary capillary wedge position) pressure waveform acquisition during right heart and pulmonary artery catheterization.

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